Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)
- National Institutes of Health - National
Institute of Neurological Disorders and Stroke awards $4.3 Million
to Manisha Patel, PhD at the University of Colorado Skaggs School
of Pharmacy and Pharmaceutical Sciences for further testing of AEOL
10150 as a nerve agent countermeasure
- When added to the current standard therapy,
AEOL 10150 improves survival to 100 percent
- AEOL 10150 also reduces oxidative stress,
provides neuroprotection and restores lung capacity
- Data presented at 6th Annual NIH CounterACT Network
Research Symposium
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology
company developing compounds to protect against radiological and
chemical threats with significant funding from the US Government,
announced today that the National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS) has
awarded a $4.3 million grant to test the effects of AEOL 10150
against soman and other nerve agents. The Grant was awarded to
Manisha Patel, PhD at the University of Colorado Skaggs School of
Pharmacy and Pharmaceutical Sciences.
Additionally, the Company announced that researchers, led by Dr.
Patel, completed a pilot study demonstrating that AEOL 10150
provides neuroprotection, decreases oxidative stress, and
significantly improves survival in rats exposed to pilocarpine -- a
surrogate for the nerve agents soman and sarin gas. These data were
presented at the 6th Annual CounterACT Countermeasures Against
Chemical Threats Network Research Symposium in Washington, D.C.,
and were included in the grant application.
The current standard of care for nerve agent exposure is
Atropine® and benzodiazepines. In this study AEOL 10150
significantly improved the survival of pilocarpine treated animals.
Detailed data is expected to be published shortly. AEOL 10150 is
the focus of a sponsored research grant awarded by the National
Institutes of Health (NIH), National Institute of Neurological
Disorders and Stroke (NINDS) and Office of the Director (OD) to the
University of Colorado to test the potential efficacy of AEOL 10150
as a medical countermeasure against nerve agents. Nerve agents,
such as sarin gas, have been used in Syria, Iraq and Japan and pose
a threat to civilian and military personnel. Sarin gas exposure can
cause pain, weakness, vomiting, diarrhea and changes in heart rate
within minutes to 18 hours after exposure. High levels of exposure
can cause convulsions, paralysis, breathing problems and death.
"Injection of AEOL10150 60 minutes after pilocarpine in the
presence of standard therapy resulted in improved survival and near
complete inhibition of oxidative stress indices in the
hippocampus," stated Manisha Patel, PhD.
"These new data show that adding AEOL 10150 to the standard of
care for nerve agent exposure results in complete survival, and
were critical to the award of this grant. We are grateful to Dr.
Patel and her team for their research and to NIH CounterACT for
their continued funding of this critical program," stated John L.
McManus, President and Chief Executive Officer of Aeolus
Pharmaceuticals, Inc. "Recent events demonstrate the danger of
chemical weapons, and highlight the importance of both the NIH
CounterACT and Biomedical Advanced Research and Development
Authority programs' funding to develop and acquire treatments for
chemical radiological, and biological threats. AEOL 10150 continues
to demonstrate its efficacy against a broad-spectrum of chemical
and radiological threats, which increases its utility as a
countermeasure to protect citizens and soldiers from these
threats."
On September 10th, NIH-NINDS notified Dr. Patel that a total of
$4.3 million had been awarded for her project titled
"Neuroprotective Effects of AEOL 10150 against organophosphate
toxicity." The research work will be conducted in Dr. Patel's lab
at the University of Colorado, National Jewish Health as well as at
the United States Army Medical Research Institute of Chemical
Defense (USAMRICD). Funding for this research has been awarded
under a grant supported by the CounterACT Program, National
Institutes of Health Office of the Director (NIH OD), and the
NINDS.
At the June 2013 NIH CounterACT meeting, Dr. Patel reported the
results from work funded under a pilot NIH CounterACT Grant awarded
to the University of Colorado were to evaluate the neuroprotective
efficacy of AEOL 10150 against pilocarpine-induced neurotoxicity in
rats. Pilocarpine is a surrogate of nerve agents. Exposure to
organophosphate nerve agents, metabolic poisons, or high levels of
sulfur mustard and pesticides can trigger seizures and loss of
consciousness. These results build on knowledge gained from
research conducted by Dr. Patel in rodent models of neurotoxicity
and neurodegeneration.
Dr. Patel's previous work confirmed AEOL 10150's ability to
cross the rat blood brain barrier and achieve sufficient levels to
exert its neuroprotective effects. Further, the study showed that
subcutaneous administration of AEOL 10150 30 min prior to or 60 and
90 minutes after nerve agent exposure resulted in inhibition of
markers of oxidative stress and neuronal damage.
AEOL 10150 is currently under development as a broad spectrum
medical countermeasure with support from the US Government. NIH
CounterACT is funding research and development of the compound as a
countermeasure against exposure to nerve agents, chlorine gas and
sulfur mustard gas. NIH-NIAID is conducting animal efficacy studies
of the compound as a countermeasure for the Gastro-Intestinal (GI)
effects of Acute Radiation Syndrome (ARS), and the Biomedical
Advanced Research and Development Authority (BARDA) has awarded the
Company a contract valued up to $118 million to develop AEOL 10150
as a countermeasure against Lung ARS/Delayed Effects of Radiation
Exposure (DEARE).
Potential for AEOL 10150 as a Countermeasure
Against Chemical Threats
AEOL 10150 has shown significant protective effects against
radiation, mustard gas, chlorine gas, phosgene gas and nerve agents
in animal models. A compound with the potential to protect against
multiple threats would be of significant benefit in both the
military and civilian efforts to protect citizens against potential
threats. The United States Food and Drug Administration (FDA) has a
special "Animal Rule" under which compounds may be approved for use
against chemical and nuclear threats on the strength of animal
efficacy studies, which allows the potential for an accelerated
approval path versus conventional pharmaceutical applications.
About AEOL 10150
AEOL 10150 is a broad-spectrum catalytic antioxidant
specifically designed to neutralize reactive oxygen and nitrogen
species. The neutralization of these species reduces oxidative
stress, inflammation, and subsequent tissue damage-signaling
cascades resulting from radiation exposure. The Company believes
that AEOL 10150 could have a profound beneficial impact on people
who are exposed to high-doses of radiation.
AEOL 10150 has already performed well in animal safety studies,
was well-tolerated in two human clinical trials, and has
demonstrated statistically significant survival efficacy in
multiple Lung-ARS studies in animals. AEOL 10150 is also currently
in development for use as both a therapeutic and prophylactic drug
in cancer patients.
About Aeolus Pharmaceuticals
Aeolus Pharmaceuticals is developing a platform of a new class
of broad-spectrum, catalytic-antioxidant compounds that protect
healthy tissue from the damaging effects of radiation. Its first
compound, AEOL 10150, is being developed, with funding by the US
Department of Health and Human Services, as a medical
countermeasure against chemical and radiological weapons, where its
initial target indications are as a protective agent against the
effects of acute radiation syndrome and delayed effects of acute
radiation exposure. Aeolus' strategy is to leverage the substantial
investment in toxicology, manufacturing, and preclinical and
clinical studies made by US Government agencies in AEOL 10150,
including the contract with BARDA valued, with options, at up to
$118.4 million, to efficiently develop the compound for use in
oncology. For more information, please visit Aeolus's corporate
website at www.aeoluspharma.com.
Forward-Looking Statements The statements
in this press release that are not purely statements of historical
fact are forward-looking statements. Such statements include, but
are not limited to, those relating to Aeolus' product candidates,
as well as its proprietary technologies and research programs, the
Company's potential initiation of large efficacy studies in mice
and NHPs, as well as a phase 1 study in healthy normal volunteers,
the BARDA Contract, and the expected use of proceeds from the
financing. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause
Aeolus' actual results to be materially different from historical
results or from any results expressed or implied by such
forward-looking statements. Important factors that could cause
results to differ include risks associated with uncertainties of
progress and timing of clinical trials, scientific research and
product development activities, difficulties or delays in
development, testing, obtaining regulatory approval, the need to
obtain funding for pre-clinical and clinical trials and operations,
the scope and validity of intellectual property protection for
Aeolus' product candidates, proprietary technologies and their
uses, and competition from other biopharmaceutical companies, and
whether BARDA exercises one or more additional options under the
BARDA Contract. Certain of these factors and others are more fully
described in Aeolus' filings with the Securities and Exchange
Commission, including, but not limited to, Aeolus' Annual Report on
Form 10-K for the year ended September 30, 2012. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof.
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Contact: John McManus President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc. 1-(949) 481-9820
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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